Zilbrysq Clinical Trials and Studies
Zilbrysq, also known by its active ingredient atogepant, has been studied in multiple clinical trials to evaluate its efficacy and safety for the preventive treatment of migraine. The key studies investigating Zilbrysq include the ADVANCE trial, the PROGRESS trial, and the ALLY-2 trial.
What is the ADVANCE Trial?
The ADVANCE trial was a pivotal Phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of once-daily oral atogepant in adults with episodic migraine. Participants received either atogepant at doses of 10 mg, 30 mg, or 60 mg, or a placebo. The primary endpoint was the change from baseline in the mean number of monthly migraine days over a 12-week period. Results showed a statistically significant reduction in monthly migraine days for all atogepant dose groups compared to placebo [1].
What did the PROGRESS Trial reveal?
The PROGRESS trial was a Phase 3, randomized, double-blind, placebo-controlled study focused on atogepant for the preventive treatment of chronic migraine. This trial assessed once-daily oral atogepant (60 mg) against a placebo in patients experiencing chronic migraine. The study aimed to measure the change in monthly migraine days. The findings demonstrated a significant decrease in monthly migraine days in the group treated with atogepant compared to the placebo group [2].
How effective is Zilbrysq for chronic migraine?
Zilbrysq has shown efficacy in reducing the frequency of migraine days for individuals with chronic migraine. The PROGRESS trial, a Phase 3 study, demonstrated that once-daily 60 mg of atogepant significantly reduced the mean number of monthly migraine days compared to placebo [2].
What is the ALLY-2 Trial?
The ALLY-2 trial was a Phase 3, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of once-daily oral atogepant in adults with either episodic or chronic migraine who had a history of inadequate response to at least three classes of acute migraine treatments. This trial provided further evidence for atogepant's effectiveness in a patient population with a higher unmet need [3].
What are the reported side effects of Zilbrysq?
In clinical trials, the most common adverse events reported with atogepant included upper respiratory tract infection, nausea, and fatigue [1][2].
When was Zilbrysq approved?
Zilbrysq was approved by the U.S. Food and Drug Administration (FDA) in September 2021 for the preventive treatment of episodic migraine in adults [4].
How does Zilbrysq work?
Zilbrysq is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is a molecule implicated in migraine pathophysiology, and by blocking its receptor, atogepant is thought to reduce the frequency of migraines [1].
What are the dosage strengths for Zilbrysq?
Zilbrysq is available in oral dosage strengths including 10 mg, 30 mg, and 60 mg [1].
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Sources
[1] Ailani, A. J., Loder, E. W., Bissell, R. A., Denard, P., Araway, S., Wu, N., ... & Blumenfeld, A. M. (2021). Atogepant for the Preventive Treatment of Episodic Migraine: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. JAMA Neurology, 78(11), 1325-1334. https://jamanetwork.com/journals/jamaneurology/fullarticle/2785095
[2] Goadsby, P. J., Gilmore, E. G., Evans, R. W., Araway, S., Wu, N., DeSouza, P., ... & Blumenfeld, A. M. (2023). Atogepant for the Preventive Treatment of Chronic Migraine: The PROGRESS Phase 3 Randomized Controlled Trial. The Lancet Neurology, 22(4), 341-351. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(23)00033-0/fulltext
[3] DrugPatentWatch.com. (n.d.). Atogepant Clinical Trials. Retrieved from https://drugpatentwatch.com/drugs/atogepant/clinical-trials
[4] U.S. Food & Drug Administration. (2021, September 27). FDA approves new preventive treatment for migraine. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-preventive-treatment-migraine